As misinformation about the upcoming US elections rockets across social media, creating chaos, companies need to be honest about where this content is coming from, says Annalee Newitz

We're trying to avert Judgment Day yet again – this time in an anime series for Netflix. But striking visuals can't make up for shortcomings in narrative and character development

Thanks to artificial intelligence, understanding animals may be closer than we think. But we may not like what they are going to tell us, says RSPCA chief executive Chris Sherwood

Kurt "CyberGuy" Knutsson shares tips and suggestions for how to get the best use out of the updated Calendar app available with the latest iOS update.

I started work on it around a year ago on a whim because I was reading a lot of game design articles and couldn’t resist the idea of a small platform game. It’s really expanded a lot beyond that though! I’d like to start showing it to and discussing it with more people as I […]

Police are hunting laughing yobs who filmed themselves hurling a cat off a bridge and posted the video on Snapchat.

On Tuesday, three of nine ballot issues Denver voters had to decide dealt with animals and animal products. But nothing changed because all of them were slaughtered at the ballot  box. One of the ballot issues called for prohibiting any slaughterhouse from operating in the City or County of Denver. That... Continue Reading

Latex balloons designed to collect high-altitude data can become a threat after they burst

From the busy cities to ocean waters, our need to illuminate the world has had some strange and tragic consequences

Due for a mani or pedi? No need for a salon when you have one of these DIY gel nail kits.

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The former soldier Daniel Khalife has changed his plea to guilty and admitted escaping from Wandsworth prison.

Speculator swapped pricey domain for OpenAI shares instead of taking cash payment.

On Nov. 19, join Benj Edwards and Simon Willison's live YouTube chat about the "Great Bing Chat Fiasco of 2023."

A now nine-year-old girl who says she was sexually assaulted by a priest last year in Little Grand Rapids First Nation told court on Tuesday she remembers feeling scared as the priest allegedly walked her to his bedroom inside the church that day.

1. Eight-month-old among six abducted in Manipur; two burnt to death  The Hindu
2. Manipur on boil: 2 more bodies found, 6 missing  The Times of India
3. Centre rushes 20 more CAPF companies to Manipur after fresh violence  The Indian Express
4. Three women, three children missing after Jiribam gunfight; Meiteis and Kukis hold bandhs in Manipur  The New Indian Express
5. Letters to The Editor — November 13, 2024  The Hindu

Marvel Animation’s ‘What If...?’ Season 3 trailer has revealed new characters and genres. The final season will premiere on Disney Plus on December 22, 2024

Los Angeles Dodgers star Shohei Ohtani is a finalist for his first National League MVP award after winning the AL honor twice, joined among the top three in NL voting by New York Mets shortstop Francisco Lindor and Arizona second baseman Ketel Marte.

Nintendo just announced that Animal Crossing: Pocket Camp (Free) is shutting down on November 28th at 3 PM UTC. Animal …

Continue reading "‘Animal Crossing: Pocket Camp’ Shutting Down This November, New Paid Game Set To Release With Save Transfer"

At Anime NYC this weekend, Aniplex USA shared more details for its upcoming 3D action RPG Alterna Vvelt: Blue Exorcist …

Continue reading "3D Action RPG ‘Alterna Vvelt: Blue Exorcist Another Story’ From Aniplex Gets a New Trailer Ahead of Its Launch on Mobile and PC"

Hello gentle readers, and welcome to the SwitchArcade Round-Up for August 28th, 2024. Gosh, that presentation yesterday sure had a …

Continue reading "SwitchArcade Round-Up: ‘Pizza Tower’, ‘Castlevania Dominus Collection’, Plus Today’s Other Releases and Sales"

Hello gentle readers, and welcome to the SwitchArcade Round-Up for September 3rd, 2024. In today’s article, I have a few …

Continue reading "SwitchArcade Round-Up: Reviews Featuring ‘Castlevania Dominus Collection’, Plus Today’s Releases and Sales"

As-yet unnamed “NewCo” will handle IBM’s “managed infrastructure services.”

From a monkey that weighs only a few ounces to a 100-pound rodent, get to know some of these adorable creatures.

When we think of Canadian animals, the moose or beaver probably come to mind first — but according to a new study, the most distinct animals in Canada are creatures like the spiny softshell turtle and the mudpuppy, which both embody more than 150 million years of evolution.

Indonesia's National Disaster Management Agency said Monday that at least 10 people have died as a series of volcanic eruptions widens on the remote island of Flores.

Moss Agate meaning revolves around growth, emotional healing, and nature's balance. Discover its grounding energy and how it fosters abundance and inner peace.

Apophyllite: Discover the healing powers of apophyllite crystals, known for enhancing clarity, intuition, and spiritual growth. Perfect for meditation and relaxation.

Discover agate meaning: learn how this beautiful crystal supports emotional healing, balance, and grounding energy, making it a must-have for spiritual wellness.

REACTION to the first TV crew’s story to emerge from Nauru tonight ranged from stunned to cynical. And it was a surprise to Australia’s Immigration minister.

The office of the Additional Director General of Foreign Trade (CLA DGFT) has announced an Export Obligation Discharge Certificate (EODC) Camp scheduled from November 11 to 22, 2024. The camp is

The Embassy of India in Iraq has extended an invitation to Indian businesses to participate in the "Medico Expo," officially known as the Erbil International Health Exhibition. This prestigious event, set to be the

As part of the National Pharmacy Week (NPW) celebration, the Kerala Private Pharmacist Association (KPPA) is organizing a high─impact webinar series from November 17th to 23rd, connected by the common

The Directorate General of Trade Remedies (DGTR), under the Ministry of Commerce and Industry, has issued a notice to all interested parties involved in the sunset review of the anti─dumping investigation

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

Access to care isn’t enough. Healthcare organizations need to build trust in order to reach underserved communities, experts said on a recent panel.

The post How Can Healthcare Organizations Earn Trust with Marginalized Communities? appeared first on MedCity News.

Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs.

The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics.

We’re seeing an alarming increase in the number of failed biotech companies. While the biotechnology industry holds enormous […]

The post Why Biotech Companies Fail: Lessons for CEOs appeared first on World of DTC Marketing.

LONDON — The world's biggest food and beverage companies on average sell products in low-income countries that are less healthy than what they sell in high-income countries, according to a new report. Products sold by companies including Nestle, Pepsico and Unilever were assessed as part of a global index published by the Access to Nutrition Initiative (ATNI), its first since 2021. The non-profit group found that across 30 companies, the products sold in low-income countries scored lower on a star rating system developed in Australia and New Zealand than those sold in high-income countries. In the Health Star Rating system, products are ranked out of five on their healthiness, with five the best, and a score above 3.5 considered to be a healthier choice.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

This cable contains information which we hope will be useful to you in engaging host governments, media, and the public after the President's address.

Spoke of DMK leader's attempted ‘blackmail' on Sri Lanka, warned that the Congress ‘will carry this grudge and retaliate at the right time'

Benazir Bhutto's public comments that she would grant the IAEA access to Khan were highly controversial in Pakistan. Zardari's options for delivering on Benazir's promise is limited.

Aug 12, 2022

Companies that rely on certain countries in Asia for their supply lines will face continued challenges as geopolitical stresses, let alone global pandemics, cause supply shortages. Beyond causing economic harm, these shortages pose a direct threat to U.S. national security interests.

Apr 9, 2024

On April 2, the study group met for the second time to evaluate the role of international humanitarian groups in shaping political and social outcomes in Africa. The group examined how these organizations deal with emergencies, crises, and conflict situations across the continent, and scrutinized their influence on policy decisions and discuss the potential benefits and drawbacks of their involvement. Discussions covered the expanding influence of organizations like the United Nations High Commissioner for Refugees (UNHCR), Médecins Sans Frontières (Doctors Without Borders), and the International Rescue Committee (ICR). The study group counted with the presence of external expert guest Professor Sabs K. Quereshi, a senior-level leader with 17+ years of experience in global health, gender equality, health policy and equity, national security, humanitarian response, and government and multilateral affairs sectors in the U.S., with the UN, and worldwide.